510(k) · Cleared
ClearedDimension Vista (TM) BHCG Flex (R) Reagent Cartridge, and BHCG Calibrator, Model# K6430,KC632
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · DHA System, Test, Human Chorionic Gonadotropin
Cleared on Feb 23, 2007 as substantially equivalent to K970387 (Dade Chemistry Systems, Inc., 1997) and 1 other predicate after a 66-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Feb 23, 2007
- Review
- 66 days
- Class
- Class II
- Product code
- DHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K970396 (1997). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK970396 Human Chorionic Gonadotropin CalibratorDade Chemistry Systems, Inc. · 1997
- This deviceK063754 Dimension Vista (TM) BHCG Flex (R) Reagent Cartridge, and BHCG…Dade Behring, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970396 | Human Chorionic Gonadotropin Calibrator | Dade Chemistry Systems, Inc. | 1997 | — |
| 0 (this device) | K063754 | Dimension Vista (TM) BHCG Flex (R) Reagent Cartridge, and BHCG Calibrator… | Dade Behring, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DHA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DHA device
- #1 K233581 VITROS Immunodiagnostic Products Total ß-hCG…score 7.6 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K970387 | Human Chorionic Gonadotropin MethodSummary page 1…I 3. Identification of the Predicate Device *Dimension®) Human Chorionic Gonadotropin (HCG) method and calibrator. (K970387/K970396). FDA Guidance Documnent(s): * "Bundling Multiple Devices or Multiple Indications in a Single S… | 1997 |
| * | K970396 | Human Chorionic Gonadotropin CalibratorSummary page 1…Identification of the Predicate Device *Dimension®) Human Chorionic Gonadotropin (HCG) method and calibrator. (K970387/K970396). FDA Guidance Documnent(s): * "Bundling Multiple Devices or Multiple Indications in a Single Submissio… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All DHA devicesDHA System, Test, Human Chorionic Gonadotropin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DHA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DHA
63in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DHA
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DHA
234in 2025
MAUDE reports naming product code DHA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 64 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 1 | — | 0 | 196 |
| 2010 | 0 | — | 2 | 179 |
| 2011 | 0 | — | 0 | 478 |
| 2012 | 0 | — | 0 | 277 |
| 2013 | 2 | — | 0 | 244 |
| 2014 | 0 | — | 0 | 119 |
| 2015 | 1 | — | 2 | 52 |
| 2016 | 0 | — | 0 | 55 |
| 2017 | 2 | — | 0 | 101 |
| 2018 | 0 | — | 1 | 103 |
| 2019 | 1 | — | 0 | 152 |
| 2020 | 1 | — | 0 | 115 |
| 2021 | 3 | 289 | 0 | 210 |
| 2022 | 1 | — | 2 | 185 |
| 2023 | 3 | 63 | 0 | 194 |
| 2024 | 1 | — | 0 | 261 |
| 2025 | 0 | — | 0 | 234 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BHCG method is an in vitro diagnostic assay for the quantitative measurement of total Beta (f3) human chorionic gonadotropin: both the intact hCG dimer and the free [3 subunit of human chorionic gonadotropin hormone in human serum and plasma on the Dimension Vistalm system. Measurements of j3 human chorionic gonadotropin are used for the early detection of pregnancy.
The BHCG calibrator is an in vitro diagnostic product for the calibration of the Beta Human Chorionic Gonadotropin method for the Dimension VistaTm System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063754 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063754: Dimension Vista (TM) BHCG Flex (R) Reagent Cartridge, and BHCG Calibrator, Model# K6430,KC632.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063754
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026